The following data is part of a premarket notification filed by Harry A. Schlakman with the FDA for Moss(r) Steel Breakaway(r) Introducer.
| Device ID | K945480 |
| 510k Number | K945480 |
| Device Name: | MOSS(R) STEEL BREAKAWAY(R) INTRODUCER |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | HARRY A. SCHLAKMAN 301 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman HARRY A. SCHLAKMAN 301 VERONA AVE. Elizabeth, NJ 07208 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-08-28 |